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NCT00203879 · ClinicalTrials.gov registry record · Phase 2

Study of MAGE-3/Melan-A/gp 100/NA17 and rhIL-12 With/Out Low Dose IL-2 in Metastatic Melanoma

A Phase 2 study of Metastatic Melanoma, sponsored by University of Chicago.

Completed
Registry status
Phase 2
Development phase
19
Enrollment target
1
Study location

NCT00203879 is a Phase 2 study of Metastatic Melanoma that has completed, run by University of Chicago. The registered enrollment target is 19 participants, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00203879, a Phase 2 study of Metastatic Melanoma, has completed, sponsored by University of Chicago.

COMPLETED
Registry status
Phase 2
Development phase
19 participants
Enrollment target
1
Study location

Study Summary

Purpose of investigation: Primary hypotheses: Immunization of patients with 4 melanoma antigen peptides will induce augmented specific IFN-y-producing CD8+ T cells against all 4 antigens simultaneously. Immunization with 4 melanoma antigen peptides will increase the response rate from 10% to 30%. Administration of low-dose IL-2 following each vaccine will result in a greater than 3-fold increase in specific T cells compared to no IL-2. Secondary hypotheses: Immunization will clear the blood of detectable circulating melanoma cells. Tumors that grow despite induction of melanoma antigen-specific T cells may lack expression of antigens, class I MHC, or the TAP peptide transporter, or may fail to show increased expression of mRNA for IFN-y or perforin. Tumors that resist vaccination may express a different array of genes than those that are susceptible to vaccination.

Conditions Studied

Interventions

  • DRUG MAGE-3/Melan-A/gp100/NA PBMC, rhIL-12 (drug)
  • DRUG MAGE-3/Melan-A/gp100/NA17 Peptide-pulsed autologous PBMC, rhIL-12 with IL-2

Study Locations (1)

Illinois

  • The University of Chicago - Chicago

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2002-02
Est. Completion 2007-05
Phase Phase 2

Sponsor

University of Chicago

796 total trials

What the Registry Record Tells You About NCT00203879

The ClinicalTrials.gov registry entry for NCT00203879 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (77% lower). The listed sponsor is University of Chicago, which has 796 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Metastatic Melanoma appearing as the primary indexed condition, and to 2 interventions - of which MAGE-3/Melan-A/gp100/NA PBMC, rhIL-12 (drug) is the first listed.

NCT00203879 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.

Frequently Asked Questions

What is clinical trial NCT00203879 about?

NCT00203879 is a clinical study titled "Study of MAGE-3/Melan-A/gp 100/NA17 and rhIL-12 With/Out Low Dose IL-2 in Metastatic Melanoma". Purpose of investigation: Primary hypotheses: Immunization of patients with 4 melanoma antigen peptides will induce augmented specific IFN-y-producing CD8+ T cells against all 4 antigens simultaneously. Immunization with 4 melanoma antigen peptides will increase the response rate from 10% to 30%. Ad...

What is the current status of trial NCT00203879?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2002-02. Estimated completion is 2007-05.

What conditions does trial NCT00203879 study?

This clinical trial studies the following conditions: Metastatic Melanoma.

What interventions are being tested in trial NCT00203879?

The interventions under investigation include: MAGE-3/Melan-A/gp100/NA PBMC, rhIL-12 (drug) (DRUG), MAGE-3/Melan-A/gp100/NA17 Peptide-pulsed autologous PBMC, rhIL-12 with IL-2 (DRUG).

Who is sponsoring clinical trial NCT00203879?

This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00203879 being conducted?

This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.